Post by lakers on Jan 15, 2016 19:30:46 GMT -5
Meet Inhaled Fentanyl. Competitor: AeroLEF, TAIFUN
books.google.com/books?id=ZwPIjKg0XukC&pg=PA444&lpg=PA444&dq=inhaled+fentanyl+as+a+method+of+pain&source=bl&ots=J8gQhf6IjT&sig=kAJ9777_Xb9iyJl5kubB3mTxJ4g&hl=en&sa=X&ved=0ahUKEwjY---dgK3KAhUO42MKHYXYA24Q6AEIUTAH#v=onepage&q=inhaled%20fentanyl%20as%20a%20method%20of%20pain&f=false
www.oindpnews.com/2011/08/akela-discontinues-inhaled-fentanyl-development-program/
Akela discontinues inhaled fentanyl development program
Akela Pharma is looking for a buyer for its Taifun fentanyl development program after Teikoku Seiyaku returned Japanese rights to the product. The dry powder inhaler (DPI) was being developed for the treatment of breakthrough pain in cancer patients. Akela is also in negotiations with another development partner, Janssen Pharmaceutica, for the return of the remaining rights. As a result of the discontinuation of the program, Akela says, it is also filing for bankruptcy of its Finnish subsidiary, Akela Pharma, Oy.
The company says that it will now focus its attention on its PharmaForm CRO, which provides contract solid dose formulation and clinical supply manufacturing services. “The discontinuation of the Fentanyl TAIFUN program enables Akela to fully deploy its management and capital resources on the profitable PharmaForm subsidiary which is a logical transformation following our successful turnaround of Akela over the past 24 months,” explained Akela President and CEO Greg McKee. “Given the market capitalization of the Company, our proven track record of dramatically increasing profitability while growing revenues, coupled with a targeted acquisition strategy, we believe that our contract manufacturing platform has the ability to enhance shareholder value without the capital requirements and risks associated with traditional drug development companies.”
www.oindpnews.com/2014/01/how-an-abandoned-inhaler-project-led-to-a-cdmo-makeover/
How an abandoned inhaler project led to a CDMO makeover
CDMO PharmaForm was reborn as Formex in 2013
A new, or at least new-ish, contract development and manufacturing company called Formex LLC launched on March 8, 2013 after its parent company, Biotech Investment Group (B.I.G.), acquired all of the assets formerly belonging to Akela Pharma subsidiary PharmForm.
Formex’s services are the same as PharmaForm’s, including formulation development and GMP clinical manufacturing for various dosage forms, including intranasal and dry powder inhalation products.
In 2012, B.I.G. Chairman Masood Tayebi saw an opportunity when PharmaForm approached the company about renting space in its 80,000 sq. ft. facility in Torrey Pines, which had been built originally for Biogen Idec. Tayebi was looking to partner with a formulation company to complement his existing drug discovery businesses, and PharmaForm was looking to move to California from Texas at the request of clients. Finding a manufacturing facility built to GMP standards would make the transition as smooth as possible, and in October 2012, PharmaForm announced that it would move into the Torrey Pines Facility.
Soon, though, it became apparent that Akela was in trouble, the result, former Akela President and CEO Rudy Emmelot says, of debts related to the company’s discontinued Taifun inhaled fentanyl development program.
When the Akela stopped development on the Taifun inhaler, then-President and CEO Greg McKee asserted that the discontinuation would allow the company “to fully deploy its management and capital resources on the profitable PharmaForm subsidiary.”
The Taifun inhaler
In December of 2012, however, Akela voluntarily delisted from the Toronto Stock Exchange, stating that “doubt remains regarding the Corporation’s ability to continue as a going concern.” Soon after, Akela signed the lease with B.I.G., and two months later, Akela announced that it was in default on the lease and that B.I.G. had foreclosed, acquiring all of its assets.
On March 11, 2013 Emmelot and all of Akela’s other board members resigned, marking the official end of that company and the beginning of Formex. Emmelot became the President and CEO of Formex, and the new company offered positions to most of PharmaForm’s employees.
Formex began operations in the facilities immediately. “There was complete continuity with no business interruption,” Emmelot says: “The one thing all along that PharmaForm, and now Formex, has wanted to ensure is that the transition had no impact on our clients.”
Akela had struggled with the Taifun inhaler program for almost a decade before giving up. The inhaled fentanyl product was originally developed in the late 1990s by Finnish pharmaceutical company Leiras. In 2003, when Akela was still known as LAB International, it acquired the inhaler by purchasing a Leiras spin-off called Focus Inhalation. Akela began work to develop the product as a treatment for breakthrough pain in cancer patients.
“Inhalation has been an inherently risky place to be operating in because of the inherent risks of the dosing mechanisms,” notes Emmelot, and since fentanyl is an opiate that is significantly more potent than morphine, questions arose related to the safety of residual amounts of fentanyl left in the inhaler. Those questions led the company to reevaluate the Taifun device’s design.
The Taifun device was a reservoir-type DPI, which meant that fentanyl would always remain inside for dosing reasons. Even if the multi-dose inhaler could be converted to single-dose, as the company contemplated, a certain amount of fentanyl would still be retained after use due to static. Regulators would naturally have concerns about the use and disposal of such a device, Emmelot acknowledges. When a European trial of the product ended in 2008 after dosing of the 13th patient, he says, the project was halted.
Masood Tayebi and Rudy Emmelot
According to Emmelot, Akela investigated the possibility of a second generation device that would take various issues into account, including child safety locks, disposal, and the potential for abuse. Its partners in the Taifun fentanyl project, Takeda and Janssen Pharmaceutica, however, questioned the economic viability of a redesign, especially given problems with other inhaler projects at the time, including the failure of Exubera inhaled insulin.
In 2011, the two companies decided to stop development of the product and return the rights to Akela. Akela hired consultants to help find new partners for the inhaled fentanyl project, Emmelot says, but “no one was interested in picking it up.” With no takers for the IP, most of the patents will eventually lapse.
Now, Emmelot says, B.I.G.’s resources will allow the company “to increase its capabilities, taking our clients further down the development pipeline,” so that “our clients can transfer when they want to transfer and not be limited by our capacity for advancing the manufacturing process.” In addition to the financial resources necessary to stabilize the company, Tayebi also brings extensive experience with life sciences, having founded BioDuro, a drug discovery CRO he later sold to PPD.
According to Tayebi, he plans to turn Formex into a full service CDMO, adding commercial manufacturing to the company’s capabilities. As part of that process, he hopes to double the size of the staff up to about 75-80 employees by the end of 2014, and he says that he plans to maintain Formex’s inhalation capabilities is part of his strategy to differentiate Formex from other CDMOs.
books.google.com/books?id=ZwPIjKg0XukC&pg=PA444&lpg=PA444&dq=inhaled+fentanyl+as+a+method+of+pain&source=bl&ots=J8gQhf6IjT&sig=kAJ9777_Xb9iyJl5kubB3mTxJ4g&hl=en&sa=X&ved=0ahUKEwjY---dgK3KAhUO42MKHYXYA24Q6AEIUTAH#v=onepage&q=inhaled%20fentanyl%20as%20a%20method%20of%20pain&f=false
www.oindpnews.com/2011/08/akela-discontinues-inhaled-fentanyl-development-program/
Akela discontinues inhaled fentanyl development program
Akela Pharma is looking for a buyer for its Taifun fentanyl development program after Teikoku Seiyaku returned Japanese rights to the product. The dry powder inhaler (DPI) was being developed for the treatment of breakthrough pain in cancer patients. Akela is also in negotiations with another development partner, Janssen Pharmaceutica, for the return of the remaining rights. As a result of the discontinuation of the program, Akela says, it is also filing for bankruptcy of its Finnish subsidiary, Akela Pharma, Oy.
The company says that it will now focus its attention on its PharmaForm CRO, which provides contract solid dose formulation and clinical supply manufacturing services. “The discontinuation of the Fentanyl TAIFUN program enables Akela to fully deploy its management and capital resources on the profitable PharmaForm subsidiary which is a logical transformation following our successful turnaround of Akela over the past 24 months,” explained Akela President and CEO Greg McKee. “Given the market capitalization of the Company, our proven track record of dramatically increasing profitability while growing revenues, coupled with a targeted acquisition strategy, we believe that our contract manufacturing platform has the ability to enhance shareholder value without the capital requirements and risks associated with traditional drug development companies.”
www.oindpnews.com/2014/01/how-an-abandoned-inhaler-project-led-to-a-cdmo-makeover/
How an abandoned inhaler project led to a CDMO makeover
CDMO PharmaForm was reborn as Formex in 2013
A new, or at least new-ish, contract development and manufacturing company called Formex LLC launched on March 8, 2013 after its parent company, Biotech Investment Group (B.I.G.), acquired all of the assets formerly belonging to Akela Pharma subsidiary PharmForm.
Formex’s services are the same as PharmaForm’s, including formulation development and GMP clinical manufacturing for various dosage forms, including intranasal and dry powder inhalation products.
In 2012, B.I.G. Chairman Masood Tayebi saw an opportunity when PharmaForm approached the company about renting space in its 80,000 sq. ft. facility in Torrey Pines, which had been built originally for Biogen Idec. Tayebi was looking to partner with a formulation company to complement his existing drug discovery businesses, and PharmaForm was looking to move to California from Texas at the request of clients. Finding a manufacturing facility built to GMP standards would make the transition as smooth as possible, and in October 2012, PharmaForm announced that it would move into the Torrey Pines Facility.
Soon, though, it became apparent that Akela was in trouble, the result, former Akela President and CEO Rudy Emmelot says, of debts related to the company’s discontinued Taifun inhaled fentanyl development program.
When the Akela stopped development on the Taifun inhaler, then-President and CEO Greg McKee asserted that the discontinuation would allow the company “to fully deploy its management and capital resources on the profitable PharmaForm subsidiary.”
The Taifun inhaler
In December of 2012, however, Akela voluntarily delisted from the Toronto Stock Exchange, stating that “doubt remains regarding the Corporation’s ability to continue as a going concern.” Soon after, Akela signed the lease with B.I.G., and two months later, Akela announced that it was in default on the lease and that B.I.G. had foreclosed, acquiring all of its assets.
On March 11, 2013 Emmelot and all of Akela’s other board members resigned, marking the official end of that company and the beginning of Formex. Emmelot became the President and CEO of Formex, and the new company offered positions to most of PharmaForm’s employees.
Formex began operations in the facilities immediately. “There was complete continuity with no business interruption,” Emmelot says: “The one thing all along that PharmaForm, and now Formex, has wanted to ensure is that the transition had no impact on our clients.”
Akela had struggled with the Taifun inhaler program for almost a decade before giving up. The inhaled fentanyl product was originally developed in the late 1990s by Finnish pharmaceutical company Leiras. In 2003, when Akela was still known as LAB International, it acquired the inhaler by purchasing a Leiras spin-off called Focus Inhalation. Akela began work to develop the product as a treatment for breakthrough pain in cancer patients.
“Inhalation has been an inherently risky place to be operating in because of the inherent risks of the dosing mechanisms,” notes Emmelot, and since fentanyl is an opiate that is significantly more potent than morphine, questions arose related to the safety of residual amounts of fentanyl left in the inhaler. Those questions led the company to reevaluate the Taifun device’s design.
The Taifun device was a reservoir-type DPI, which meant that fentanyl would always remain inside for dosing reasons. Even if the multi-dose inhaler could be converted to single-dose, as the company contemplated, a certain amount of fentanyl would still be retained after use due to static. Regulators would naturally have concerns about the use and disposal of such a device, Emmelot acknowledges. When a European trial of the product ended in 2008 after dosing of the 13th patient, he says, the project was halted.
Masood Tayebi and Rudy Emmelot
According to Emmelot, Akela investigated the possibility of a second generation device that would take various issues into account, including child safety locks, disposal, and the potential for abuse. Its partners in the Taifun fentanyl project, Takeda and Janssen Pharmaceutica, however, questioned the economic viability of a redesign, especially given problems with other inhaler projects at the time, including the failure of Exubera inhaled insulin.
In 2011, the two companies decided to stop development of the product and return the rights to Akela. Akela hired consultants to help find new partners for the inhaled fentanyl project, Emmelot says, but “no one was interested in picking it up.” With no takers for the IP, most of the patents will eventually lapse.
Now, Emmelot says, B.I.G.’s resources will allow the company “to increase its capabilities, taking our clients further down the development pipeline,” so that “our clients can transfer when they want to transfer and not be limited by our capacity for advancing the manufacturing process.” In addition to the financial resources necessary to stabilize the company, Tayebi also brings extensive experience with life sciences, having founded BioDuro, a drug discovery CRO he later sold to PPD.
According to Tayebi, he plans to turn Formex into a full service CDMO, adding commercial manufacturing to the company’s capabilities. As part of that process, he hopes to double the size of the staff up to about 75-80 employees by the end of 2014, and he says that he plans to maintain Formex’s inhalation capabilities is part of his strategy to differentiate Formex from other CDMOs.